No effects on the immune system in pivotal studies
“Further, no hormonal perturbation, histopathological changes in endocrine or reproductive organs or effects on the immune system were observed in pivotal non-clinical studies.”
Wide extravascular distribution in pigmented and albino rats; likely melanin binding
“A single-dose tissue distribution study in pigmented and albino rats demonstrated that rimegepant is widely distributed extravascularly and likely binds to melanin.”
“It is difficult to dismiss this finding as not drug-related, considering evidence of intravascular hemolysis in other studies of rimegepant in monkey and rat in the absence of microscopic findings.”
✓ VerifiedFDA pharmacology/toxicology review, p. 4Source ↗